Alemtob (Drops) Instructions for Use

Marketing Authorization Holder

Alembic Pharmaceuticals Limited (India)

ATC Code

S01AA12 (Tobramycin)

Active Substance

Tobramycin (Rec.INN registered by WHO)

Dosage Form

Alemtob

Eye drops 0.3%: 5 ml bottle, 1 pc.

Dosage Form, Packaging, and Composition

Eye drops in the form of a transparent, colorless or light yellow solution.

Excipients : benzalkonium chloride – 0.1 mg, sodium sulfate – 3 mg, boric acid – 15 mg, sodium borate – 3 mg, disodium edetate – 0.5 mg, thiourea – 0.05 mg, sodium hydroxide 20% – q.s. to pH 7.0-8.0, water for injections – up to 1 ml.

5 ml – low-density polyethylene bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Antibiotic for topical use in ophthalmology

Pharmacotherapeutic Group

Antibiotic-aminoglycoside

Pharmacological Action

A broad-spectrum antibiotic from the aminoglycoside group. In low concentrations, it acts bacteriostatically (blocks the 30S ribosomal subunit and disrupts protein synthesis), and in higher concentrations, it acts bactericidally (disrupts the function of cytoplasmic membranes, causing the death of the microbial cell).

Highly active against Staphylococcus spp. (including Staphylococcus aureus, Staphylococcus epidermidis /coagulase-negative and coagulase-positive/, as well as penicillin-resistant strains); Streptococcus spp. (including α-β-hemolytic species, some non-hemolytic species, Streptococcus pneumoniae); Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis (indole-negative) and indole-positive species of Proteus spp., Haemophilus influenzae, Haemophilus aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus (Herellea vaginicola), some species of Neisseria spp. (including Neisseria gonorrhoeae).

Pharmacokinetics

With topical application, systemic absorption is low.

Indications

Blepharitis; conjunctivitis; keratoconjunctivitis; blepharoconjunctivitis; keratitis; iridocyclitis; prevention of postoperative complications in ophthalmology.

ICD codes

Dosage Regimen

Instill one to two drops into the affected eye(s) every four hours.

For severe infections, increase the frequency to one to two drops every hour until improvement is observed, then reduce the frequency.

For postoperative prophylaxis, apply one to two drops into the conjunctival sac four times daily for a duration of seven to ten days, or as directed.

Do not touch the dropper tip to any surface to avoid contamination.

Wash hands before use. Tilt head back, pull lower eyelid down, and instill drops. Close eye and apply gentle pressure to the nasolacrimal duct for one to two minutes to minimize systemic absorption.

The typical treatment course is seven to ten days. Do not discontinue therapy prematurely, even if symptoms improve.

If using other topical ophthalmic products, administer them at least five minutes apart.

Discard the bottle four weeks after first opening to prevent microbial contamination.

Adverse Reactions

Allergic reactions itching and swelling of the eyelids, conjunctival hyperemia, lacrimation. Burning sensation and foreign body sensation in the eye may occur.

Contraindications

Hypersensitivity to tobramycin, children under 1 year of age, breastfeeding period.

Use in Pregnancy and Lactation

There is insufficient experience with the use of the drug during pregnancy and breastfeeding. Use during pregnancy is not recommended. Use during breastfeeding is contraindicated.

Pediatric Use

Contraindicated for use in children under 1 year of age.

Geriatric Use

Use with caution in elderly patients to avoid the risk of exacerbation of chronic diseases.

Special Precautions

Cross-hypersensitivity to other aminoglycosides may develop, and the possibility should be considered that patients who have developed hypersensitivity to topical tobramycin may also be sensitive to other topical and/or systemic aminoglycosides.

Serious adverse reactions, including neurotoxicity, ototoxicity, and nephrotoxicity, may occur in patients receiving systemic tobramycin therapy. Use caution when combining topical Tobramycin with systemic aminoglycosides.

Use with caution in patients with suspected or confirmed neuromuscular disorders, such as Parkinson’s disease or myasthenia gravis. Aminoglycosides may exacerbate muscle weakness due to a potential effect on neuromuscular conduction.

Prolonged use of the antibiotic may lead to overgrowth of non-susceptible microorganisms, including fungi. If superinfection occurs, appropriate therapy should be instituted.

Patients whose visual acuity is temporarily reduced after using tobramycin are not recommended to engage in activities requiring increased attention and quick reactions until it is restored.

Drug Interactions

With simultaneous use of topical tobramycin with systemic aminoglycoside antibiotics, systemic side effects may be enhanced.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.